A number of publications as listed at the end of this specification are incorporated herein by reference in their entireties for background information and are numerically referenced in the following text.
Intracranial aneurysms are the main cause of nontraumatic subarachnoid hemorrhage and are responsible for about 25% of all deaths relating to cerebrovascular events. Autopsy studies show that the overall frequency of intracranial aneurysms in the general population is approximately 5 percent and suggest that 10 to 15 million persons in the United States have or will have intracranial aneurysms [1]. In approximately 15,000 cases (6 cases per 100,000 persons per year), intracranial aneurysms rupture every year in North America [2]. Rupture of intracranial aneurysms leads to subarachnoid aneurysmal hemorrhage (SAH) which has a 30-day mortality rate of 45%, and results in approximately half the survivors sustaining irreversible brain damage [1, 2].
The primary goal of treatments for intracranial aneurysm is prevention of the rupture of the aneurysms, thereby preventing bleeding or rebleeding. At the present time, three general methods of treatment exist. These can be grouped according to their approach: extravascular, endovascular, and extra-endovascular.
The extravascular approach involves surgery or microsurgery of the aneurysm. One surgical procedure is to apply a metallic clip or a suture-ligation across the artery feeding the aneurysm (neck), thereby allowing the aneurysm to clot off and hopefully shrink. Another surgical procedure is to “surgically reconstruct” the aneurysmal portion of the artery, by surgically cut out the aneurysm and repairing the vessel by using a natural or synthetic vessel graft. Both of these surgical procedures typically require general anesthesia, craniotomy, brain retraction, and dissection of the arachnoid around the neck of the aneurysm.
Surgical treatment of vascular intracranial aneurysm is accompanied by a mortality rate of 3.8% and a morbidity rate of 10.9% [3]. Because of the high mortality and morbidity rates, and because the condition of many patients does not permit them to undergo an open operation, the surgical procedure is often delayed or not practical. For this reason the prior art has sought alternative means of treatment.
The development of microcatheters made possible the use of endovascular (catheter-based) procedures. The major advantage of the endovascular procedures is that they do not require the use of open surgery. They are generally more beneficial and have much lower mortality and morbidity rates than the extravascular procedures.
Many variations of endovascular procedures exist of which some of the more important are the following:
Placement of embolic material, such as metallic microcoils or spherical beads, inside the aneurysm sac in order to form a mass within this sac which will slow the blood flow and generally encourage the aneurysm to clot off and to shrink. To accomplish this procedure, a microcatheter is guided through the cerebral arteries until the site of the aneurysm is reached. The distal tip of the microcatheter is then placed within the sac of the aneurysm, and the embolic material is injected into the sac of the aneurysm. Typical microcatheters suitable for this procedure are disclosed in U.S. Pat. Nos. 5,853,418; 6,066,133; 6,165,198 and 6,168,592.
Widespread, long-term experience with this technique has shown several risks and limitations. The method has 4% morbidity and 1% mortality rate and achieves complete aneurysm occlusion in only 52% to 78% of the cases in which it is employed. The relatively low success rate is due to technical limitations (e.g., coil flexibility, shape, and dimensions) which prevent tight packing of the sac of the aneurysm, especially aneurysms with wide necks [3]. Other difficulties are associated with the presence of preexisting thrombus within the aneurysm cavity, which may be sheared off into the parent trunk leading to parent artery occlusion. Also aneurysm perforation may occur during placement of coils into the aneurysm. Additionally, occurrence of coil movement and compaction may foster aneurysm revascularization or growth.
2. Another endovascular technique for treating aneurysms involves inserting a detachable balloon into the sac of the aneurysm using a microcatheter. The detachable balloon is then inflated using embolic material, such as a liquid polymer material or microcoils. The balloon is then detached from the microcatheter and left within the sac of the aneurysm in an attempt to fill the sac and to form a thrombotic mass inside the aneurysm.
One of the disadvantages of this method is that detachable balloons, when inflated, typically do not conform to the interior configuration of the aneurysm sac. Instead, the aneurysm sac is forced to conform to the exterior surface of the detachable balloon. Thus, there is an increased risk that the detachable balloon will rupture the sac of the aneurysm.
3. Stent technology has been applied to the intracranial vasculature. The use of this technology has been limited until recently by the lack of available stents and stent delivery systems capable of safe and effective navigation through the intercranial vessels. The use of such stents is particularly difficult with respect to aneurysms in head blood vessels because of the number of perforating vessels in such blood vessels, and thereby the increased danger that one or more perforating vessels may be in the vicinity of such an aneurysm. The same is true with respect to bifurcations of a blood vessel splitting into one or more branch vessels, which may also be in the vicinity of an aneurysm. Where the blood supply to an aneurysm is to be reduced, it is critical that the blood supply to such perforating vessel or branch vessels, in the vicinity of the aneurysm not be unduly reduced to the degree causing damage to the tissues supplied with blood by such perforating or branch vessels.
Thus, there is a serious danger that the placement of a conventional endovascular stent within the parent artery across the aneurysm neck to reduce blood flow to the aneurysm, to promote intra-aneurysm stasis and thrombosis [4, 5].
Stents having portions of different permeabilities are disclosed, for example, in McCrory U.S. Pat. No. 5,951,599, Brown et al U.S. Pat. No. 6,093,199, Wallsten U.S. Pat. No. 4,954,126, and Dubrul U.S. Pat. No. 6,258,115.
The McCrory patent discloses a braided stent having a first portion with a relatively high porosity index so as to be highly permeable to blood flow, and a second portion of lower porosity index so as to be less permeable to blood flow. When the stent is deployed, the portion of low permeability is located to overlie the neck of the aneurysm, and the portion of high permeability is spaced from the neck of the aneurysm. A braided stent construction with different porosities is also disclosed in the Dubrul patent.
Brown et al, on the other hand, discloses an intraluminal device or stent comprising a diverter, in the form of a low-permeability foam pad, to overlie the neck of the aneurysm, straddled on its opposite sides by a pair of high-permeability coil elements for anchoring the device in the blood vessel.
Wallsten U.S. Pat. No. 4,954,126, discloses a braided tube intraluminal device for use in various applications, one of which applications is to apply a graft to treat an aneurysm (FIG. 9). In this case, the complete braided tube would have high permeability with respect to blood flow therethrough since its function is to mount the grafts, but the graft would have low-permeability to decrease the possibility of rupture of the aneurysm.
Delivery devices for stents for use in the intracranial vasculature are well known at the art. Typical devices are disclosed, for example, in the following U.S. Pat. Nos. 5,496,275; 5,676,659; and 6,254,628. The blood vessels in the brain are frequently as small as several millimeters, requiring that the catheters have an outside diameter as small as 2-8 French (0.66 mm to 2.64 mm).
Technically it is very difficult to produce and accurately deploy the stents described in the above McCrory, Brown et al and Wallsten patents for treating aneurysms by using presently available delivery systems. The difficulties include not only in producing such stents of different permeabilities, but also in deploying them such that the portion of low permeability is exactly aligned with the aneurysm neck. When the device is to be implanted in a blood vessel having an aneurysm at or proximate to a perforating vessel or a bifurcation leading to a branch vessel, the portion of high permeability must be precisely located at the perforating or branch vessels in order to maintain patency in the perforating or branch vessels. Additionally, particularly in tortuous, ectatic vessels, existing stiff stents are difficult to introduce and may results in kinking such as to cause the failure of the deployment process.
Furthermore, none of the prior art mentioned is suitable for use with a basal apex aneurysm.
For these reasons it is apparent that there is a need for a better intraluminal device to treat an aneurysm, particularly an intracranial aneurysm, and more particularly an intracranial aneurysm proximate to a bifurcation.